inforMED
InjuryEGJ

EBPRO

Received Mar 12, 2020 · Event occurred Feb 12, 2020

Report MW5093715 · MDR key 9828877

Device

Generic name

Device, Iontophoresis, Other Uses

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

25 YR

  • Dizziness
  • Dizziness

Narrative

Description of Event or Problem

THIS IS REGARDING THE EBPRO BY ERCHONIA CORP. I AM A USER OF THE DEVICE. I CAN SMELL CHLORINE GAS DURING AND IMMEDIATELY AFTER USING THE DEVICE IN A CLOSED ROOM OF THE SIZE OF APPROX 8X8X8 FEET. PURE TABLE SALT WAS ADDED TO THE WATER BATH, PER INSTRUCTIONS IN THE MANUAL. TAP WATER WAS USED, BUT THE WATER WASN'T HEAVILY CHLORINATED. I EXPERIENCED DIZZINESS DURING AND AFTER TREATMENT. THE SYMPTOMS SUBSIDED WHEN I WALKED OUT TO AN OPEN SPACE. I SUSPECT THE DEVICE PRODUCES CHLORINE GAS, WITH THE CHLORIDE ELEMENT COMING FROM THE TABLE SALT NACL. FDA SAFETY REPORT ID# (B)(4).